Pediatric Cancer Studies: US FDA Promises Flexible Approach On Requirements

FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.

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The US FDA is promising to take a flexible, transparent approach to the development and implementation of new pediatric study requirements for certain cancer drugs under the FDA Reauthorization Act (FDARA).

The agency intends use a transparent process to generate a list of molecular targets potentially relevant to pediatric cancers and...

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